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Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.
Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.
Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.
Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.
Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.
Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.
Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.
Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.
Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.
Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.
Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.
Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.
Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.
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Takeda is a patient-focused, innovation-driven global pharmaceutical company that builds on a distinguished 235-year history, aspiring to bring better health and a brighter future for people worldwide.
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At Takeda, you will make a positive impact on people’s lives every day–including your own. It’s important to us that our employees feel they are empowered to perform to the very best of their ability as every member of our team is working towards bringing better health and a brighter future to millions of people worldwide.
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Takeda has maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
Supervises a staff performing a wide range of biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. Position may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. This position is responsible for results in terms of product quality and conformance to regulations and quality policies. In some instances, this position may be responsible for a functional area and may not have subordinates.
Job Function and Description
- Ensure completion of all testing, including raw materials, in-process, final release, stability, and special project/protocol testing in a timely manner that achieves fulfillment to commitments.
- Implement and continuously improve quality systems to ensure compliance with testing SOPs and specification. Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems.
- Monitor testing techniques and review accuracy of records and documentation generated.
- Lead and/or support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams. Will lead complex investigations.
- Perform routine walk throughs and compliance checks to verify adherence to quality guidelines.
- Interact with inspectors in regulatory audits to represent area of responsibility.
- Lead laboratory audit ready status efforts in understanding FDA and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
- Proactively lead initiatives to contribute to build a strong team and increase efficiency, solve problems, resolve operational issues, generate cost savings, and improve quality.
- Adhere to established expenditure controls to support management of laboratory budget.
- Ensure a safe and accountable working environment for employees by adhering to company work rules, policies, and safety standards.
- Manage and ensure that nonconformance events (OOL, OOS, etc.) are completed in an effective and timely manner. Ensure extension requests are filled out in a timely manner.
- Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans. Create performance improvement plans (PIP) where necessary.
- Ensure employees are properly trained and/or qualified and periodically audited. Ensure personal training requirements are met and that training records are current.
- Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, and other appropriate documentation for proper functioning of the lab operation.
- Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 5+ years of related experience. Some leadership experience preferred.
Key Skills, Abilities, and Competencies
- Working knowledge of statistics and production processes.
- Strong communication skills are needed to effectively supervise support personnel.
- Must have AS400 or PC knowledge.
Complexity and Problem Solving
• Able to follow directions.
• Able to identify when proper practices/ procedures are not performed.
• Follow SOPs and identify processes and results.
• Execute changes and corrections.
• Self-starting and task proficient.
• Escalate accordingly.
• Ensures timely communication of issues.
• Ensure appropriate communication between personnel, groups, and between departments.
• Coordinates activities, schedules staff, etc.
Internal and External Contacts
Position acts as a support function to manufacturing operations and is required to routinely coordinate testing activities and communication of results with IG, Fractionation, and Albumin. In addition, the individual will also correspond with other support functions such as QA, Engineering, Maintenance, etc. Position may be required to participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.
Other Job Requirements
• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shift hours.
• Must be able to work supplemental hours as necessary to complete work commitments.
• May be required to work in a confined area.
• Primarily inside working conditions.
• Some clean room and cool/hot storage conditions.
Position may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and/ or Laboratory Operations with general job requirements summarized below:
• Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconciliation of test results.
• Environmental monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.
• Manage and investigation of nonconformance events (OOL, OOS, etc.). Develop and deploy the site Contamination Control Master Plan (CCMP).
• Development, validation, and optimization of departmental assays.
• Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0032253
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